Full Press Release Details
Phase 3 CATT1 completion of enrollment on track for the third quarter of 2026
Strong balance sheet expected to fund operations through anticipated CATT1 topline data readout
HIGH POINT, N.C., May 13, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development ofcadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. The Company continues to advance its Phase 3 CATT1 trial, with enrollment on track for completion in the third quarter of 2026. vTv expects its current cash position to be sufficient to fund operations through the anticipated CATT1 topline data readout, positioning the Company to reach this key value inflection point with cash currently on hand.
“We are executing with focus and discipline as we advancecadisegliatin, a potentially transformative, first-in-class oral therapy for people living with type 1 diabetes,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. “Enrollment in our Phase 3 CATT1 trial continues to progress steadily, supported by expanded site activation and strong engagement from both investigators and patients. Importantly, with our recently strengthened balance sheet, we are well-capitalized to deliver on completion of enrollment and the anticipated topline data readout and drive long-term value for shareholders.”
Recent Company Highlights
• Phase 3 CATT1 Trial Progressing:Enrollment is ongoing in the Phase 3 CATT1 trial evaluatingcadisegliatinas an oral adjunctive therapy to insulin in individuals with T1D. The Company expects to complete enrollment in the third quarter of 2026, supported by expanded site activation and increased investigator and patient engagement.
• License Amendment Adds Non-Dilutive Capital:In February 2026, the Company announced an amendment to its license agreement with Newsoara Biopharma, granting Newsoara global rights to the Company's highly selective PDE4 inhibitor, HPP737. Under the amended agreement, the Company received a $20.0 million upfront payment and is eligible to receive up to approximately $50.0 million in development milestones, up to $65.0 million in sales milestones, and tiered royalties on net sales. The transaction strengthens the Company's balance sheet and maintains strategic focus on advancingcadisegliatin.
First Quarter 2026 Financial Results
• Cash Position: Cash and cash equivalents as of March 31, 2026, were $98.1 million, compared to $88.9 million as of December 31, 2025. The increase reflects the $20.0 million upfront payment received under the recent amendment to the Newsoara license, partially offset by operating expenditures.
• Research & Development (R&D) Expenses: R&D expenses were $9.0 million and $2.8 million in each of the three months ended March 31, 2026, and 2025, respectively. The increase was primarily driven by continued investment in the Phase 3 CATT1 trial.
• General & Administrative (G&A) Expenses:G&A expenses were $4.6 million and $3.7 million for each of the three months ended March 31, 2026, and 2025, respectively. The increase reflects ongoing support for corporate operations and clinical development activities.
• Interest Income:Interest income for the three months ended March 31, 2026, and 2025, of $0.8 million and $0.3 million, respectively, is related to dividend income from our money market accounts.
• Net Income (Loss): Net income attributable to vTv shareholders for the three months ended March 31, 2026, was $24.1 million or $1.94 and $1.65 per basic and diluted share, respectively. Net loss attributable to vTv shareholders for the comparable period a year ago was $5.1 million or $0.77 per basic and diluted share.
Upcoming Events
• H.C. Wainwright 4th Annual BioConnect Investor ConferenceFormat: Fireside Chat & 1x1 Investor MeetingsDate: Tuesday, May 19, 2026Time: 12:30 PM ETLocation: New York, NYWebcast Link
• Alliance Global Partners Healthcare Company ShowcaseFormat: Fireside ChatDate: Wednesday, May 20, 2026Time: 4:20 PM ETLocation: VirtualEvent Webcast Link
| vTv Therapeutics Inc.Condensed Consolidated Balance Sheets(in thousands) | |||||||
| March 31,2026 | December 31,2025 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 98,086 | $ | 88,932 | |||
| Prepaid expenses | 521 | 743 | |||||
| Other current assets | 201 | 218 | |||||
| Total current assets | 98,808 | 89,893 | |||||
| Other assets | 5 | 6 | |||||
| Total assets | $ | 98,813 | $ | 89,899 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 6,821 | $ | 6,557 | |||
| Warrant liability, related party | 60 | 84 | |||||
| Total current liabilities | 6,881 | 6,641 | |||||
| Contract liabilities | 1,830 | 18,669 | |||||
| Warrant liability | 143 | 152 | |||||
| Total liabilities | 8,854 | 25,462 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Class A Common Stock | 39 | 39 | |||||
| Class B Common Stock | — | — | |||||
| Additional paid-in capital | 392,478 | 391,090 | |||||
| Accumulated deficit | (302,558 | ) | (326,692 | ) | |||
| Total stockholders’ equity | 89,959 | 64,437 | |||||
| Total liabilities and stockholders’ equity | $ | 98,813 | $ | 89,899 | |||
| vTv Therapeutics Inc.Condensed Consolidated Statements of Operations(in thousands, except per share data) | |||||||
| Three Months EndedMarch 31, | |||||||
| 2026 | 2025 | ||||||
| (Unaudited) | |||||||
| Revenue | $ | 36,839 | $ | — | |||
| Operating expenses: | |||||||
| Research and development | 8,978 | 2,830 | |||||
| General and administrative | 4,598 | 3,673 | |||||
| Total operating expenses | 13,576 | 6,503 | |||||
| Operating income/(loss) | 23,263 | (6,503 | ) | ||||
| Interest income | 838 | 331 | |||||
| Other income (expense), net | 33 | (45 | ) | ||||
| Net income (loss) before income taxes and noncontrolling interest | 24,134 | (6,217 | ) | ||||
| Income tax provision | — | — | |||||
| Net income (loss) before noncontrolling interest | 24,134 | (6,217 | ) | ||||
| Less: net loss attributable to noncontrolling interest | — | (1,125 | ) | ||||
| Net income (loss) attributable to vTv Therapeutics Inc. | $ | 24,134 | $ | (5,092 | ) | ||
| Net income (loss) attributable to vTv Therapeutics Inc. common shareholders | $ | 24,134 | $ | (5,092 | ) | ||
| Basic net income (loss) per share of vTv Therapeutics Inc. Class A common stock | $ | 1.94 | $ | (0.77 | ) | ||
| Basic weighted average number of vTv Therapeutics Inc. Class A common stock | 12,409,278 | 6,582,844 | |||||
| Diluted net income (loss) per share of vTv Therapeutics Inc. Class A common stock | $ | 1.65 | $ | (0.77 | ) | ||
| Diluted weighted average number of vTv Therapeutics Inc. Class A common stock | 14,634,420 | 6,582,844 | |||||
About vTv Therapeutics
vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv's clinical pipeline is led bycadisegliatin, currently in a U.S. Phase 3 trial, a potential first-in-class oral glucokinase activator being investigated for the treatment of type 1 diabetes. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more atvtvtherapeutics.comor follow the company onLinkedInorX.
About Cadisegliatin
Cadisegliatin (TTP399)is a novel, oral small molecule, liver-selective glucokinase activator being investigated in the U.S. as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D). In non-clinical studies,cadisegliatinacted selectively on the liver and increased glucokinase activity independently of insulin. These findings support clinical investigation of whether cadisegliatincan improve glycemic control through hepatic glucose uptake and glycogen storage.Cadisegliatinhas been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).
Cadisegliatinis under investigation, and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.
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, the anticipated effect of Phase 3 topline data on the Company, the benefits ofcadisegliatinto people living with T1D, 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, subsequent Quarterly Reports on Form 10-Q 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 our forward-looking statements by these cautionary statements.