FALSE0001641489Nasdaq00016414892024-05-092024-05-09
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): May 9, 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 2.02 Results of Operations and Financial Condition
On May 9, 2024, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended March 31, 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
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Exhibit No. | | Description |
99.1 | | |
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: | President and Chief Executive Officer | |
Dated: May 9, 2024
Exhibit 99.1 vTv Therapeutics Announces 2024 First Quarter Financial Results and Provides Corporate Update
HIGH POINT, N.C. – May 9, 2024 – vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today reported financial results for the first quarter ended March 31, 2024, and provided an update on recent corporate developments.
“The first quarter of 2024 saw us reach several important milestones, which we believe position vTv well for continued execution of our corporate and clinical development strategy,” said Paul Sekhri, Chief Executive Officer of vTv. “The proceeds of the private placement we announced at the end of February are expected to fully fund the first Phase 3 study of cadisegliatin in patients with T1D, for which we expect to report top line data in the first quarter of 2026. Site activation activities for this trial are well underway and we continue to expect enrollment of the first patient during the second quarter. We believe that the body of evidence generated to-date, including the data from the Phase 2 SimpliciT-1 study provides a compelling scientific rationale supporting the potential of cadisegliatin as an adjunctive therapy to insulin for the treatment of this highly prevalent disease. In parallel with the upcoming launch of this Phase 3 study, we are in the planning stages for two international registrational trials of cadisegliatin in T1D which we expect to initiate in 2026. We are also continuing our close collaboration with G42 Investments to support the launch of the planned Phase 2 trial in the Middle East evaluating cadisegliatin in 450 T2D patients currently on insulin therapy. That trial remains on-track to commence in the second half of 2024.”
Recent Company Highlights
•Significantly strengthened the Company’s balance sheet through a $51 million private placement with healthcare-focused institutional investors and the JDRF T1D Fund. The proceeds of the private placement are expected to fund the continued development of cadisegliatin through top-line data from the first Phase 3 study, which is anticipated by the first quarter of 2026.
•On March 4, 2024, the Company announced the submission to the FDA of the protocol for the first Phase 3 clinical trial of cadisegliatin in patients with T1D. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 150 patients at up to 20 sites in the U.S., with the first patient expected to be enrolled in the second quarter. It will assess two doses of cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use continuous glucose monitoring. The primary efficacy endpoint of the study is the incidence of Level 2 or Level 3 hypoglycemic events.
First Quarter 2024 Financial Results
•Cash Position: The Company’s cash position as of March 31, 2024, was $52.3 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 $2.6 million and $3.9 million in each of the three months ended March 31, 2024, and 2023, respectively. The decrease of $1.3 million is primarily attributable to lower spending on cadisegliatin, due to decreases in i) toxicity study costs and drug manufacturing
related costs, partially offset by increases in clinical trial start-up costs and ii) an increase in indirect costs and other projects.
•General & Administrative (G&A) Expenses: G&A expenses were $4.0 million and $3.5 million for each of the three months ended March 31, 2024 and 2023, respectively. The increase of $0.5 million was primarily due to increases in legal expense and higher payroll costs offset by lower other G&A costs and share-based expense.
•Other (Expense)/Income: Other expense for the three months ended March 31, 2024, was $0.4 million and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties. Other income for the three months ended March 31, 2023, was $1.6 million and was driven by an unrealized gain related to our investment in Reneo, losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties and the loss from the G42 promissory note early redemption.
•Net Loss: Net loss attributable to vTv shareholders for the three months ended March 31, 2024, was $4.9 million or $1.17 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $4.5 million or $2.16 per basic share.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
| (Unaudited) | | |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 52,255 | | | $ | 9,446 | |
Accounts receivable | 981 | | | 102 | |
| | | |
Prepaid expenses and other current assets | 571 | | | 1,044 | |
Current deposits | 65 | | | 65 | |
Total current assets | 53,872 | | | 10,657 | |
Property and equipment, net | 95 | | | 117 | |
Operating lease right-of-use assets | 216 | | | 244 | |
| | | |
Total assets | $ | 54,183 | | | $ | 11,018 | |
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity (Deficit) | | | |
Current liabilities: | | | |
Accounts payable and accrued expenses | $ | 8,731 | | | $ | 10,242 | |
Current portion of operating lease liabilities | 173 | | | 169 | |
Current portion of contract liabilities | 17 | | | 17 | |
Current portion of notes payable | — | | | 191 | |
Total current liabilities | 8,921 | | | 10,619 | |
Contract liabilities, net of current portion | 18,669 | | | 18,669 | |
Operating lease liabilities, net of current portion | 125 | | | 169 | |
Warrant liability, related party | 481 | | | 110 | |
Total liabilities | 28,196 | | | 29,567 | |
Commitments and contingencies | | | |
Redeemable noncontrolling interest | — | | | 6,131 | |
Stockholders’ equity (deficit): | | | |
Class A Common Stock | 24 | | | 21 | |
Class B Common Stock | 6 | | | 6 | |
| | | |
Additional paid-in capital | 306,887 | | | 256,335 | |
Accumulated deficit | (286,121) | | | (281,042) | |
Total stockholders’ equity (deficit) attributable to vTv Therapeutics Inc. | 20,796 | | | (24,680) | |
Noncontrolling interest | 5,191 | | | — | |
Total stockholders’ equity (deficit) | 25,987 | | | (24,680) | |
Total liabilities, redeemable noncontrolling interest and stockholders’ equity (deficit) | $ | 54,183 | | | $ | 11,018 | |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data) | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2024 | | 2023 | | | | |
| (Unaudited) | | |
Revenue | $ | 1,000 | | $ | — | | | | |
Operating expenses: | | | | | | | |
Research and development | 2,649 | | 3,942 | | | | |
General and administrative | 3,978 | | 3,485 | | | | |
Total operating expenses | 6,627 | | 7,427 | | | | |
Operating loss | (5,627) | | (7,427) | | | | |
Interest income | 79 | | 100 | | | | |
| | | | | | | |
Other (expense) income, net | (371) | | 1,553 | | | | |
Loss before income taxes and noncontrolling interest | (5,919) | | (5,774) | | | | |
Income tax provision | 100 | | — | | | | |
Net loss before noncontrolling interest | (6,019) | | (5,774) | | | | |
Less: net loss attributable to noncontrolling interest | (1,154) | | (1,275) | | | | |
Net loss attributable to vTv Therapeutics Inc. | $ | (4,865) | | $ | (4,499) | | | | |
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (4,865) | | | $ | (4,499) | | | | | |
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted (*) | $ | (1.17) | | | $ | (2.16) | | | | | |
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted (*) | 4,141,492 | | | 2,084,973 | | | | | |
(*) Adjusted retroactively for reverse stock split | | | | | | | |
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 cadisegliatin (TTP399), a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications including type 2 diabetes and other chronic conditions.
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,” "seek," “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:
Lee Roth
Burns McClellan
lroth@burnsmc.com
Media:
Selina Husain / Robert Flamm, Ph.D.
Burns McClellan, Inc.
shusain@burnsmc.com / rflamm@burnsmc.com
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