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 11, 2023
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File No.) | (IRS Employer Identification No.) | ||||||
(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) | |||||
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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 11, 2023, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended June 30, 2023. 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 | ||||||||
| 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: August 11, 2023
Exhibit 99.1vTv Therapeutics Announces 2023 Second Quarter Financial Results and Provides Corporate Update
HIGH POINT, N.C. - August 11, 2023 – vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today reported financial results for the second quarter ended June 30, 2023 and provided an update on recent corporate developments.
“In the first half of 2023, we made further progress in the development of cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes," said Paul Sekhri, Chief Executive Officer of vTv. "The Breakthrough Therapy Designation granted to cadisegliatin has enabled us to actively engage with the FDA to align on the design and conduct of the planned Phase 3 study. Further, our partners at Cantex Pharmaceuticals have made exciting progress on the development of azeliragon, a small-molecule RAGE inhibitor discovered by vTv, as a potential treatment for a variety of oncology and related indications. Overall, we believe we are well positioned heading into the second half of the year and look forward to providing updates, as appropriate, on our partnered programs as well as cadisegliatin as we advance toward the initiation of Phase 3 study activities, which we continue to expect by year-end. The initial phase 3 study will test the FDA’s recommended primary endpoint, which is the reduction in the number of hypoglycemic events between placebo and cadisegliatin treated groups."
Recent Company Highlights
•On July 17, 2023, the Company received notice from Nasdaq that it had approved the Company’s request to extend the period for the Company to regain compliance with the Minimum Bid Requirement until December 18, 2023.
Second Quarter 2023 Financial Results
•Cash Position: The Company’s cash position as of June 30, 2023 was $12.6 million compared to $12.1 million as of December 31, 2022.
•Research & Development (R&D) Expenses: R&D expenses were $4.7 million and $2.2 million in each of the three months ended June 30, 2023 and 2022, respectively. The increase of $2.5 million is primarily attributable to higher spending on cadisegliatin, due to increases in drug product related costs, and an increase in indirect costs related to the development of cadisegliatin.
•General & Administrative (G&A) Expenses: G&A expenses were $3.3 million and $1.8 million for each of the three months ended June 30, 2023 and 2022, respectively. The increase of $1.5 million was primarily due to higher payroll cost and higher other G&A costs.
•Other Income (Expense): 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 stock issued to related parties. Other expense for the three months ended June 30, 2022 was $0.1 million and was driven by an unrealized loss related to the
investment in Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party.
•Net Loss: Net loss attributable to vTv shareholders for the three months ended June 30, 2023 was $5.6 million or $0.07 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $3.2 million or $0.04 per basic share.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| June 30, 2023 | December 31, 2022 | ||||||||||
| (Unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 12,599 | $ | 12,126 | |||||||
| Accounts receivable | — | 173 | |||||||||
| G42 Promissory Note receivable | — | 12,243 | |||||||||
| Prepaid expenses and other current assets | 1,324 | 2,537 | |||||||||
| Current deposits | 15 | 15 | |||||||||
| Total current assets | 13,938 | 27,094 | |||||||||
| Property and equipment, net | 162 | 207 | |||||||||
| Operating lease right-of-use assets | 299 | 349 | |||||||||
| Long-term investments | 8,027 | 5,588 | |||||||||
| Total assets | $ | 22,426 | $ | 33,238 | |||||||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | 9,108 | $ | 7,313 | |||||||
| Current portion of operating lease liabilities | 161 | 154 | |||||||||
| Current portion of contract liabilities | 17 | 17 | |||||||||
| Current portion of notes payable | — | 224 | |||||||||
| Total current liabilities | 9,286 | 7,708 | |||||||||
| Contract liabilities, net of current portion | 18,669 | 18,669 | |||||||||
| Operating lease liabilities, net of current portion | 256 | 338 | |||||||||
| Warrant liability, related party | 619 | 684 | |||||||||
| Total liabilities | 28,830 | 27,399 | |||||||||
| Commitments and contingencies | |||||||||||
| Redeemable noncontrolling interest | 18,879 | 16,579 | |||||||||
| Stockholders’ deficit: | |||||||||||
| Class A Common Stock | 815 | 815 | |||||||||
| Class B Common Stock | 232 | 232 | |||||||||
| Additional paid-in capital | 254,479 | 253,737 | |||||||||
| Accumulated deficit | (280,809) | (265,524) | |||||||||
| Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (25,283) | (10,740) | |||||||||
| Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 22,426 | $ | 33,238 | |||||||
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||||||||||
| Revenue | $ | — | $ | 9 | $ | — | $ | 2,009 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 4,691 | 2,205 | 8,633 | 5,338 | |||||||||||||||||||
| General and administrative | 3,309 | 1,831 | 6,794 | 7,179 | |||||||||||||||||||
| Total operating expenses | 8,000 | 4,036 | 15,427 | 12,517 | |||||||||||||||||||
| Operating loss | (8,000) | (4,027) | (15,427) | (10,508) | |||||||||||||||||||
| Interest income | 153 | 50 | 253 | 50 | |||||||||||||||||||
| Interest expense | (2) | — | (2) | (1) | |||||||||||||||||||
| Other income (expense), net | 638 | (114) | 2,191 | (2,856) | |||||||||||||||||||
| Loss before income taxes and noncontrolling interest | (7,211) | (4,091) | (12,985) | (13,315) | |||||||||||||||||||
| Income tax provision | — | — | — | 200 | |||||||||||||||||||
| Net loss before noncontrolling interest | (7,211) | (4,091) | (12,985) | (13,515) | |||||||||||||||||||
| Less: net loss attributable to noncontrolling interest | (1,592) | (940) | (2,867) | (3,357) | |||||||||||||||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (5,619) | $ | (3,151) | $ | (10,118) | $ | (10,158) | |||||||||||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,619) | $ | (3,151) | $ | (10,118) | $ | (10,158) | |||||||||||||||
| Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted | $ | (0.07) | $ | (0.04) | $ | (0.12) | $ | (0.15) | |||||||||||||||
| Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted | 81,483,600 | 70,366,823 | 81,483,600 | 68,664,259 | |||||||||||||||||||
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 adjunctive therapy to insulin 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 glioblastoma and other cancers and cancer treatment-related 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,” “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 cadisegliatin. 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