vTv Therapeutics Announces 2025 First Quarter Financial Results and Provides Corporate Update
- Protocol amendment reduces CATT1 trial duration from 12 to 6 months, accelerating time to topline data
- Healthy cash position of $31.1 million as of Q1 2025
- Reduced G&A expenses from $4.0M to $3.7M year-over-year
- Potential to be first oral adjunct therapy for Type 1 Diabetes
- Net loss increased to $5.1 million from $4.9 million year-over-year
- Cash position decreased by $5.6 million from Q4 2024
- No revenue generated in Q1 2025 compared to $1 million in Q1 2024
- R&D expenses increased to $2.8 million from $2.6 million year-over-year
Insights
vTv's Phase 3 diabetes drug faces extended timeline to 2H 2026 despite protocol amendments to accelerate development.
vTv Therapeutics has provided a significant update on their lead asset cadisegliatin, a potential first-in-class oral adjunctive therapy for type 1 diabetes (T1D). The company has recently reinitiated screening for their Phase 3 CATT1 trial, which represents a critical milestone in their clinical development program.
The most notable development is their strategic protocol amendment to reduce the trial duration from 12 to 6 months. This modification aims to accelerate time to topline data, now expected in 2H 2026, by eliminating an extended safety assessment period. Importantly, the company states this won't impact the primary endpoints, suggesting confidence in detecting efficacy signals within the shortened timeframe.
The addition of continuous glucose monitors (CGM) to the trial protocol is particularly meaningful for T1D research. CGMs provide more comprehensive glycemic data than traditional finger-stick measurements, potentially yielding richer insights into cadisegliatin's effects on glycemic variability and time-in-range metrics – parameters increasingly valued by regulatory authorities and clinicians.
The company's cash position of $31.1 million represents a $5.6 million decrease from year-end 2024, reflecting a quarterly burn rate that may become concerning if enrollment and trial execution extend longer than anticipated. With topline data now targeted for late 2026 – more than a year away – the company likely needs to secure additional funding to support operations through this critical readout.
R&D expenses increased slightly year-over-year despite reduced clinical trial and manufacturing costs for cadisegliatin, indicating potential reallocation of resources rather than true cost savings. The net loss of
vTv's amended Phase 3 diabetes trial timeline pushes revenue potential to 2027+ with concerning cash burn rate.
vTv Therapeutics' Q1 results and pipeline update reveal critical financial and developmental considerations for investors. The company's cash runway appears increasingly tight, with
With topline Phase 3 data for cadisegliatin now projected for 2H 2026 following the protocol amendment, vTv faces at least six more quarters of operations before this critical inflection point. At the current burn rate, this would consume
The protocol amendment reducing the CATT1 trial from 12 to 6 months represents a strategic pivot that accelerates the development timeline but raises questions about the ultimate regulatory package. While the company indicates no impact on key endpoints, the elimination of extended safety data could potentially influence the comprehensiveness of a future FDA submission, especially for a chronic treatment in diabetes where safety profiles are scrutinized extensively.
From a valuation perspective, vTv's entirely clinical-stage pipeline centered on a single lead asset creates significant binary risk. The
The market opportunity for an oral adjunctive therapy in type 1 diabetes remains substantial, but with commercialization now unlikely before 2027 at the earliest, investors face an extended timeline to potential revenue generation.
Ongoing screening in CATT1 Phase 3 trial evaluating cadisegliatin in patients with type 1 diabetes (T1D)
Topline Phase 3 data for cadisegliatin expected in 2H 2026
HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical 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 first quarter ended March 31, 2025, and provided an update on recent corporate developments.
“Our late stage cadisegliatin program is advancing with potential to be the first oral adjunct therapy for T1D,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “We reinitiated screening in our Phase 3 CATT1 study and, based upon the recent protocol amendment to shorten the study from 12 to 6 months, we expect topline Phase 3 data for cadisegliatin in the second half of 2026.”
Recent Company Highlights
- Screening Reinitiated for Cadisegliatin Phase 3 Trial. In May 2025, vTv Therapeutics announced that screening has been reinitiated in the Company’s CATT1 phase 3 trial evaluating cadisegliatin as an adjunctive therapy to insulin for treatment of type 1 diabetes (T1D). Topline data from the study is expected in the second half of 2026.
- Protocol Amendment for CATT1 Phase 3 Trial. In April, the Company submitted a protocol amendment to reduce the overall duration of the CATT1 trial from 12 to 6 months, which will expedite time to topline data by forgoing the additional 6-month safety assessment with no impact on original key endpoints. Also based on the amendment, continuous glucose monitors (CGM) will now be provided to participants.
First Quarter 2025 Financial Results
- Cash Position: The Company’s cash position as of March 31, 2025, was
$31.1 million compared to$36.7 million as of December 31, 2024. - Research & Development (R&D) Expenses: R&D expenses were
$2.8 million and$2.6 million in each of the three months ended March 31, 2025, and 2024, respectively. The increase reflects higher indirect costs and other project-related expenses. This was partially offset by lower spending on cadisegliatin, primarily due to reduced clinical trial costs and drug manufacturing costs and lower spending on other projects. - General & Administrative (G&A) Expenses: G&A expenses were
$3.7 million and$4.0 million for each of the three months ended March 31, 2025, and 2024, respectively. The decrease was primarily due to decreases in payroll costs, legal expense and other operating costs. This was partially offset by an increase in share-based expense. - Other Expense, Net: Other expense for the three months ended March 31, 2025, was immaterial. 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 own stock issued to related parties. - Net Loss: Net loss attributable to vTv shareholders for the three months ended March 31, 2025, was
$5.1 million or$0.77 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was$4.9 million or$1.17 per basic share.
| vTv Therapeutics Inc. Condensed Consolidated Balance Sheets (in thousands) | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 31,059 | $ | 36,746 | |||
| Prepaid expenses | 742 | 1,192 | |||||
| Other current assets | 115 | 175 | |||||
| Total current assets | 31,916 | 38,113 | |||||
| Property and equipment, net | 19 | 28 | |||||
| Operating lease right-of-use assets | 92 | 125 | |||||
| Total assets | $ | 32,027 | $ | 38,266 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 4,191 | $ | 5,027 | |||
| Current portion of operating lease liabilities | 125 | 169 | |||||
| Total current liabilities | 4,316 | 5,196 | |||||
| Contract liabilities, net of current portion | 18,669 | 18,669 | |||||
| Warrant liability, related party | 85 | 57 | |||||
| Warrant liability | 60 | 43 | |||||
| Total liabilities | 23,130 | 23,965 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Class A Common Stock | 26 | 26 | |||||
| Class B Common Stock | 6 | 6 | |||||
| Additional paid-in capital | 312,698 | 311,885 | |||||
| Accumulated deficit | (304,810 | ) | (299,718 | ) | |||
| Total stockholders’ equity attributable to vTv Therapeutics Inc. | 7,920 | 12,199 | |||||
| Noncontrolling interest | 977 | 2,102 | |||||
| Total stockholders’ equity | 8,897 | 14,301 | |||||
| Total liabilities and stockholders’ equity | $ | 32,027 | $ | 38,266 | |||
| vTv Therapeutics Inc. Condensed Consolidated Statements of Operations (in thousands, except per share data) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| (Unaudited) | |||||||
| Revenue | $ | — | $ | 1,000 | |||
| Operating expenses: | |||||||
| Research and development | 2,830 | 2,649 | |||||
| General and administrative | 3,673 | 3,978 | |||||
| Total operating expenses | 6,503 | 6,627 | |||||
| Operating loss | (6,503 | ) | (5,627 | ) | |||
| Interest income | 331 | 79 | |||||
| Other expense, net | (45 | ) | (371 | ) | |||
| Loss before income taxes and noncontrolling interest | (6,217 | ) | (5,919 | ) | |||
| Income tax provision | — | 100 | |||||
| Net loss before noncontrolling interest | (6,217 | ) | (6,019 | ) | |||
| Less: net loss attributable to noncontrolling interest | (1,125 | ) | (1,154 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. | $ | (5,092 | ) | $ | (4,865 | ) | |
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,092 | ) | $ | (4,865 | ) | |
| Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted | $ | (0.77 | ) | $ | (1.17 | ) | |
| Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted | 6,582,844 | 4,141,492 | |||||
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 to insulin for type 1 diabetes (T1D). In nonclinical 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 Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes.
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.
Investor Contact
Sandya von der Weid
LifeSci Advisors, LLC
svonderweid@lifesciadvisors.com
Media Contact
Caren Begun
TellMed Strategies
201-396-8551
caren.begun@tmstrat.com
FAQ
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