Form 8-K - Current report

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): July 26, 2024

vTv Therapeutics Inc.

(Exact name of registrant as specified in its charter)


Delaware	001-37524	47-3916571
(State or other jurisdiction of incorporation)	(Commission File No.)	(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 8.01 Other Events.

On July 26, 2024, vTv Therapeutics Inc. (the “Company”) issued a press release titled, "vTv Therapeutics Announces Cadisegliatin Program for Type 1 Diabetes Placed on Clinical Hold". A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d)Exhibits


Exhibit No.						Description
99.1						P res s Release dated July 26, 2024 titled "vT v Therapeutics Announces Ca disegliatin Program for Type 1 Diabetes Placed on Clinical Hold"
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/ Paul J. Sekhri
			Name:			Paul J. Sekhri
			Title:			Chairman, President, and Chief Executive Officer

Dated: July 26, 2024

vTv Therapeutics Announces Cadisegliatin Program for Type 1 Diabetes Placed on Clinical Hold

HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment.

The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. The Agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.

“Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”

About Cadisegliatin

Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator with first-in- class potential as an adjunct treatment for type 1 diabetes (T1D). Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.

About vTv Therapeutics

vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class adjunctive therapy to insulin for the treatment of type 1 diabetes.

Forward-Looking Statement

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.

Contact

Ashley Robinson

LifeSci Advisors, LLC

arr@lifesciadvisors.com

Cover	Jul. 26, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jul. 26, 2024
Entity Registrant Name	vTv Therapeutics Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-37524
Entity Tax Identification Number	47-3916571
Entity Address, Address Line One	3980 Premier Drive, 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
Amendment Flag	false
Entity Central Index Key	0001641489