vTv Therapeutics reports Phase 3 trial initiation for cadisegliatin in type 1 diabetes, with expanded patents and strengthened leadership.
Quiver AI Summary
vTv Therapeutics Inc. announced the randomization of the first participant in its Phase 3 CATT1 trial evaluating cadisegliatin as a potential adjunctive therapy for type 1 diabetes, with results expected in the second half of 2026. The company has also expanded its intellectual property portfolio related to cadisegliatin and strengthened its leadership team with the appointment of a new Chief Financial Officer. Financially, vTv reported a net loss of $6.0 million for the second quarter of 2025 and a cash position of $25.9 million. Cadisegliatin is being developed as a novel oral treatment intended to improve glycemic control and reduce hypoglycemic risk for those with type 1 diabetes.
Potential Positives
- First study participant randomized in Phase 3 CATT1 trial for cadisegliatin, highlighting progress in the development of a potential first-in-class therapy for type 1 diabetes.
- Expansion of the intellectual property portfolio for cadisegliatin with the allowance of a patent for crystalline salt forms, potentially providing a competitive advantage and longer market exclusivity.
- Appointment of a new Chief Financial Officer with significant experience in financial management and strategic leadership, strengthening the leadership team and suggesting a commitment to robust financial oversight.
Potential Negatives
- Company reported a net loss of $6.0 million for the three months ended June 30, 2025, an increase from a net loss of $5.2 million in the same period last year, indicating worsening financial performance.
- Cash position decreased significantly from $36.7 million at the end of 2024 to $25.9 million by June 30, 2025, raising concerns about liquidity and financial sustainability.
- Absence of any reported revenue during the quarter raises questions about the company's commercialization prospects and ability to generate income in the near term.
FAQ
What is cadisegliatin and its purpose?
Cadisegliatin is a potential first-in-class oral adjunctive therapy for type 1 diabetes, designed to improve glycemic control alongside insulin.
When is the expected data release from the CATT1 trial?
Topline data from the CATT1 Phase 3 trial of cadisegliatin is expected in the second half of 2026.
What recent corporate changes has vTv Therapeutics made?
vTv Therapeutics has strengthened its leadership team by appointing Michael Tung as Chief Financial Officer and expanded its intellectual property portfolio.
How much cash did vTv Therapeutics have as of June 30, 2025?
As of June 30, 2025, vTv Therapeutics reported a cash position of $25.9 million.
What role does glucokinase activation play in cadisegliatin's treatment?
Cadisegliatin selectively activates glucokinase in the liver, aiming to improve glycemic control and reduce hypoglycemia risk in type 1 diabetes patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$VTVT Hedge Fund Activity
We have seen 9 institutional investors add shares of $VTVT stock to their portfolio, and 6 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- NORTHERN TRUST CORP added 15,626 shares (+inf%) to their portfolio in Q1 2025, for an estimated $270,642
- CONNECTIVE CAPITAL MANAGEMENT, LLC added 9,377 shares (+inf%) to their portfolio in Q1 2025, for an estimated $162,409
- UBS GROUP AG removed 3,472 shares (-46.2%) from their portfolio in Q1 2025, for an estimated $60,135
- VANGUARD GROUP INC added 1,617 shares (+3.9%) to their portfolio in Q2 2025, for an estimated $24,255
- MORGAN STANLEY removed 400 shares (-34.9%) from their portfolio in Q1 2025, for an estimated $6,928
- TOWER RESEARCH CAPITAL LLC (TRC) added 394 shares (+inf%) to their portfolio in Q1 2025, for an estimated $6,824
- ROYAL BANK OF CANADA removed 376 shares (-98.2%) from their portfolio in Q1 2025, for an estimated $6,512
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$VTVT Analyst Ratings
Wall Street analysts have issued reports on $VTVT in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- HC Wainwright & Co. issued a "Buy" rating on 04/09/2025
To track analyst ratings and price targets for $VTVT, check out Quiver Quantitative's $VTVT forecast page.
Full Release
• First study participant randomized in Phase 3 CATT1 trial evaluating cadisegliatin for the treatment of type 1 diabetes with data expected in second half of 2026
• Cadisegliatin intellectual property portfolio expanded
• Leadership team strengthened
HIGH POINT, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin , a 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 second quarter ended June 30, 2025, and provided an update on recent corporate developments.
“The randomization of the first participant in our CATT1 Phase 3 trial earlier this month reflects our continued momentum in advancing c adisegliatin ,” said Paul Sekhri, Chairman, President and CEO of vTv Therapeutics. “C adisegliatin is designed to selectively activate glucokinase in the liver, a differentiated approach that may improve glycemic control and reduce the risk of hypoglycemia when used alongside insulin. Hypoglycemic episodes remain frequent, life-disruptive, and sometimes life-threatening for people with type 1 diabetes. We believe cadisegliatin could play a meaningful role in addressing this large unmet medical need . ”
Recent Company Highlights
- First Study Participant Randomized in Cadisegliatin Phase 3 Trial. In August 2025, vTv Therapeutics announced that the first study participant was randomized in the Company’s CATT1 Phase 3 Trial evaluating cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D. Topline data from the study is expected in the second half of 2026. (link to press release)
- Patent Allowance for Crystalline Salt Form of Cadisegliatin . In August 2025, the United States Patent and Trademark Office allowed claims for a patent application directed to compositions of matter of crystalline forms of salts and co-crystals of cadisegliatin . The patent term runs through 2041. (link to press release)
- Corporate Presentation at HCW@Home. In June 2025, the Company participated in a virtual fireside chat as part of the H.C. Wainwright HCW@Home series. (link to webcast replay)
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Appointment of Chief Financial Officer.
In May 2025, vTv Therapeutics appointed Michael Tung, MD, MBA, as Chief Financial Officer. Dr. Tung brings over 20 years of financial management, investment experience, and strategic leadership across both private and public life sciences companies.
(link to press release)
Second Quarter 2025 Financial Results
- Cash Position: The Company’s cash position as of June 30, 2025, was $25.9 million compared to $36.7 million as of December 31, 2024.
- Research & Development (R&D) Expenses: R&D expenses were $4.1 million and $3.4 million in each of the three months ended June 30, 2025, and 2024, respectively. The increase reflects higher indirect costs primarily related to payroll expenses. This was partially offset by lower spending on cadisegliatin and other projects.
- General & Administrative (G&A) Expenses: G&A expenses were $3.6 million and $3.7 million for each of the three months ended June 30, 2025, and 2024, respectively. The decrease was primarily due to decreases in other operating costs. This was partially offset by an increase in payroll related costs.
- Other Income, Net: Other income for the three months ended June 30, 2025, was immaterial. 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 issued to related parties.
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Net Loss:
Net loss attributable to vTv shareholders for the three months ended June 30, 2025, was $6.0 million or $0.92 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $5.2 million or $0.81 per basic share.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets (in thousands) |
||||||||
June 30,
2025 |
December 31,
2024 |
|||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 25,922 | $ | 36,746 | ||||
Prepaid expenses | 359 | 1,192 | ||||||
Other current assets | 93 | 175 | ||||||
Total current assets | 26,374 | 38,113 | ||||||
Property and equipment, net | 16 | 28 | ||||||
Operating lease right-of-use assets | 58 | 125 | ||||||
Total assets | $ | 26,448 | $ | 38,266 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 5,216 | $ | 5,027 | ||||
Current portion of operating lease liabilities | 79 | 169 | ||||||
Total current liabilities | 5,295 | 5,196 | ||||||
Contract liabilities, net of current portion | 18,669 | 18,669 | ||||||
Warrant liability, related party | 31 | 57 | ||||||
Warrant liability | 48 | 43 | ||||||
Total liabilities | 24,043 | 23,965 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Class A Common Stock | 26 | 26 | ||||||
Class B Common Stock | 6 | 6 | ||||||
Additional paid-in capital | 313,586 | 311,885 | ||||||
Accumulated deficit | (310,856 | ) | (299,718 | ) | ||||
Total stockholders’ equity attributable to vTv Therapeutics Inc. | 2,762 | 12,199 | ||||||
Noncontrolling interest | (357 | ) | 2,102 | |||||
Total stockholders’ equity | 2,405 | 14,301 | ||||||
Total liabilities and stockholders’ equity | $ | 26,448 | $ | 38,266 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations (in thousands, except per share data) |
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Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | 1,000 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,103 | 3,439 | 6,933 | 6,088 | ||||||||||||
General and administrative | 3,618 | 3,716 | 7,291 | 7,694 | ||||||||||||
Total operating expenses | 7,721 | 7,155 | 14,224 | 13,782 | ||||||||||||
Operating loss | (7,721 | ) | (7,155 | ) | (14,224 | ) | (12,782 | ) | ||||||||
Interest income | 275 | 553 | 606 | 632 | ||||||||||||
Other income (expense), net | 66 | 193 | 21 | (178 | ) | |||||||||||
Loss before income taxes and noncontrolling interest | (7,380 | ) | (6,409 | ) | (13,597 | ) | (12,328 | ) | ||||||||
Income tax provision | — | — | — | 100 | ||||||||||||
Net loss before noncontrolling interest | (7,380 | ) | (6,409 | ) | (13,597 | ) | (12,428 | ) | ||||||||
Less: net loss attributable to noncontrolling interest | (1,334 | ) | (1,229 | ) | (2,459 | ) | (2,383 | ) | ||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (6,046 | ) | $ | (5,180 | ) | $ | (11,138 | ) | $ | (10,045 | ) | ||||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (6,046 | ) | $ | (5,180 | ) | $ | (11,138 | ) | $ | (10,045 | ) | ||||
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted | $ | (0.92 | ) | $ | (0.81 | ) | $ | (1.69 | ) | $ | (1.97 | ) | ||||
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted | 6,587,070 | 6,403,444 | 6,584,969 | 5,098,877 |
About
Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D). In non-clinical studies, cadisegliatin , acting selectively on the liver, increased the activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage.
Cadisegliatin is 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.
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 by cadisegliatin , currently in a 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 at vtvtherapeutics.com or follow the company on LinkedIn or X .
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 our forward-looking statements by these cautionary statements.
Investor Contact
John Fraunces
LifeSci Advisors, LLC
917-355-2395
[email protected]
Media Contact
Caren Begun
TellMed Strategies
201-396-8551
[email protected]