FALSE0001641489Nasdaq00016414892024-08-082024-08-08

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):  August 8, 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 classTrading Symbol(s)Name of each exchange on which registered
Class A common stock, par value $0.01 per shareVTVT
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 August 8, 2024, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended June 30, 2024.  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
104Cover 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:President and Chief Executive Officer
Dated: August 8, 2024


newvtvimage30042424a.jpg                            Exhibit 99.1
vTv Therapeutics Announces 2024 Second Quarter Financial Results and Provides Corporate Update
Screened first patient in cadisegliatin pivotal trial for type 1 diabetes (T1D); working to resolve clinical hold
Expanded Newsoara Biopharma license agreement for PDE4 inhibitor HPP737 to a global license effective upon payment of the $20 million upfront fee
HIGH POINT, N.C., August 8, 2024 (GLOBENEWSWIRE) – vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today reported financial results for the second quarter ended June 30, 2024, and provided an update on recent corporate developments.
“Our small molecule portfolio continues to make significant progress across our partnered and Company driven programs. We were pleased to amend our license with Newsoara Biopharma for PDE4 inhibitor, HPP737, to make it a global license contingent upon receipt of the required upfront fee. Azeliragon, a Cantex-partnered program, recently received Orphan Drug Designation in pancreatic cancer and is advancing in several mid- to late-stage clinical trials with broad indication potential,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “We were pleased to initiate our pivotal trial in T1D for cadisegliatin, our liver selective glucokinase activator with first-in-class potential in T1D. We are working to resolve our clinical hold and resume the study as quickly as possible. Cadisegliatin has shown a favorable safety profile and has been dosed in over 500 subjects to date, including 300 patients with type 1 and type 2 diabetes. We are encouraged at the potential of cadisegliatin as an oral therapy for improved glycemic control.”
Recent Company Highlights
•Screened First Patient in Cadisegliatin Pivotal Trial for T1D. In June, vTv Therapeutics screened the first patient in the Company’s CATT1 pivotal trial evaluating cadisegliatin as an adjunct treatment of T1D. CATT1 is one of several trials that are planned to form the core of the future regulatory registrational submission for cadisegliatin, a potential first-in-class, oral, liver selective, glucokinase activator for T1D. In July, vTv Therapeutics announced the Food and Drug Administration (FDA) placed a clinical hold on the cadisegliatin clinical program following 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 FDA requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient was dosed in the CATT1 pivotal study at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. vTv Therapeutics is actively working with the FDA to resolve the clinical hold as quickly as possible. Cadisegliatin has previously been granted Breakthrough Therapy designation by the FDA for T1D and has shown clinical potential to improve glycemic control and reduce hypoglycemia in patients with diabetes.
•Expanded to a Global Licensing Agreement for HPP737 with Newsoara Biopharma. In June, vTv Therapeutics amended our license with Newsoara Biopharma for PDE4 inhibitor, HPP737, to make it a global license upon receipt of the required $20 million upfront fee. The terms of the amendment include up to $41 million in development milestones, up to $35 million in sales-related milestones, and royalties in the mid to upper single digits based on sales.


•Orphan Drug Designation Granted for Azeliragon. In May, Cantex Pharmaceuticals, Inc. announced that the FDA has granted Orphan Drug Designation to azeliragon, a well-tolerated once-a-day oral RAGE antagonist, for the treatment of pancreatic cancer. Azeliragon has also received Orphan Drug Designation for the treatment of glioblastoma. Under our license agreement with Cantex, vTv Therapeutics has the potential to receive 20 – 40% of out licensing income or the fair value of the program in the event of a sale of Cantex, or 20% of Cantex’s net profit from commercial sales. Cantex is evaluating azeliragon in several ongoing Phase 2 trials in cancer indications and one Phase 3 trial for acute kidney injury.
Second Quarter 2024 Financial Results

•Cash Position: The Company’s cash position as of June 30, 2024, was $45.5 million compared to $9.4 million as of December 31, 2023. The increase is attributed to receipt of the proceeds from the private placement financing on February 27, 2024.

•Research & Development (R&D) Expenses: R&D expenses were $3.4 million and $4.7 million in each of the three months ended June 30, 2024, and 2023, respectively. The decrease of $1.3 million is primarily attributable to lower spending on cadisegliatin, due to decreases in toxicity study costs and drug manufacturing related costs, partially offset by increases in clinical trial start-up costs and an increase in indirect costs and other projects.
•General & Administrative (G&A) Expenses: G&A expenses were $3.7 million and $3.3 million for each of the three months ended June 30, 2024, and 2023, respectively. The increase of $0.4 million was primarily due to increases in share-based expense, legal expense and higher payroll costs, partially offset by lower other G&A costs.
•Other Income, Net: Other income for the three months ended June 30, 2024, was $0.2 million and was driven by gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock. Other income for the three months ended June 30, 2023, was $0.6 million and was driven by an unrealized gain related to our investment in Reneo, as well as gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to related parties.
•Net Loss: Net loss attributable to vTv shareholders for the three months ended June 30, 2024, was $5.2 million or $0.81 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $5.6 million or $2.69 per basic share.


vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
June 30,
2024		December 31,
2023
(Unaudited)
Assets
Current assets:
Cash and cash equivalents$45,526 $9,446 
Accounts receivable306 102 
Prepaid expenses and other current assets303 1,044 
Current deposits65 65 
Total current assets46,200 10,657 
Property and equipment, net72 117 
Operating lease right-of-use assets186 244 
Total assets$46,458 $11,018 
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses$6,791 $10,242 
Current portion of operating lease liabilities177 169 
Current portion of contract liabilities17 17 
Current portion of notes payable— 191 
Total current liabilities6,985 10,619 
Contract liabilities, net of current portion18,669 18,669 
Operating lease liabilities, net of current portion79 169 
Warrant liability, related party158 110 
Warrant liability130 — 
Total liabilities26,021 29,567 
Commitments and contingencies
Redeemable noncontrolling interest— 6,131 
Stockholders’ equity (deficit):
Class A Common Stock24 21 
Class B Common Stock6 6 
Additional paid-in capital307,746 256,335 
Accumulated deficit(291,301)(281,042)
Total stockholders’ equity (deficit) attributable to vTv Therapeutics Inc.16,475 (24,680)
Noncontrolling interest3,962 — 
Total stockholders’ equity (deficit) 20,437 (24,680)
Total liabilities, redeemable noncontrolling interest and stockholders’ equity (deficit)$46,458 $11,018 


vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
(Unaudited)(Unaudited)
Revenue $— $— $1,000 $— 
Operating expenses:
Research and development 3,439 4,691 6,088 8,633 
General and administrative 3,716 3,309 7,694 6,794 
Total operating expenses 7,155 8,000 13,782 15,427 
Operating loss(7,155)(8,000)(12,782)(15,427)
Interest income553 153 632 253 
Other income (expense), net
193 638 (178)2,191 
Loss before income taxes and noncontrolling interest(6,409)(7,211)(12,328)(12,985)
Income tax provision— — 100 — 
Net loss before noncontrolling interest(6,409)(7,211)(12,428)(12,985)
Less: net loss attributable to noncontrolling interest(1,229)(1,592)(2,383)(2,867)
Net loss attributable to vTv Therapeutics Inc.$(5,180)$(5,619)$(10,045)$(10,118)
Net loss attributable to vTv Therapeutics Inc. common shareholders$(5,180)$(5,619)$(10,045)$(10,118)
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted (*)
$(0.81)$(2.69)$(1.97)$(4.85)
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted (*)
6,403,444 2,084,973 5,098,877 2,084,973 
(*) Adjusted retroactively for reverse stock split

About vTv Therapeutics
vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv's clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are investigating additional indications including type 2 diabetes and other chronic conditions.
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 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 our forward-looking statements by these cautionary statements.

Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com

v3.24.2.u1
Cover
Aug. 08, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Aug. 08, 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
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