10-Q: vTv Therapeutics Reports Q1 2025 Results, CATT1 Trial Reinitiated After Clinical Hold Lifted

Sentiment:

Quarterly Report 15 May 2025 8:07 PM

vTv Therapeutics announces its Q1 2025 financial results and the reinitiation of the CATT1 trial for cadisegliatin following the lifting of a clinical hold by the FDA.

Capital raiseThe company is evaluating several financing strategies to increase its cash runway, including direct equity investments and the potential licensing and monetization of other Company programs.The company has sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold.

Worse than expectedThe company reported no revenue for the quarter.The company reported a net loss of $5.092 million.The company has an accumulated deficit of $304.8 million.The company's financial statements include a going concern warning.

Summary

vTv Therapeutics Inc. is a clinical-stage pharmaceutical company focused on metabolic and inflammatory diseases.
The company's lead program is cadisegliatin, a liver-selective glucokinase activator (GKA) in development as an adjunctive therapy to insulin for type 1 diabetes (T1D).
The FDA had previously placed a clinical hold on the cadisegliatin program, including the CATT1 trial, but this hold was lifted on March 14, 2025.
The CATT1 trial, assessing the effect of cadisegliatin on reducing hypoglycemia frequency in 150 patients with type 1 diabetes, has been reinitiated, with the first subject screened in May 2025.
The company expects top-line data from the CATT1 study in the second half of 2026 due to a protocol amendment shortening the trial duration from 12 to 6 months.
vTv Therapeutics is also working on the design for two international registrational studies for cadisegliatin in type 1 diabetes, expected to start in 2027.
A Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes, in partnership with G42 Investments, is expected to begin in 2025.
For the three months ended March 31, 2025, the company reported no revenue and a net loss attributable to vTv Therapeutics Inc. of $5.092 million, or $0.77 per share.
As of March 31, 2025, the company had cash and cash equivalents of $31.1 million and an accumulated deficit of $304.8 million.
The company is evaluating several financing strategies to increase its cash runway, including direct equity investments and the potential licensing and monetization of other Company programs.
The company's financial statements have been prepared assuming the company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business.

Sentiment

Score: 5

Explanation: The sentiment is neutral. While the lifting of the clinical hold is a positive development, the company's financial results are weak, and there is a going concern warning. The company's future depends on raising additional capital and the successful development of its drug candidates.

Positives

The FDA lifted the clinical hold on the cadisegliatin program, allowing the CATT1 trial to resume.
The CATT1 trial has been reinitiated, with the first subject screened in May 2025.
The company expects top-line data from the CATT1 study in the second half of 2026.
The company is working on the design for two international registrational studies for cadisegliatin in type 1 diabetes, expected to start in 2027.
A Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes, in partnership with G42 Investments, is expected to begin in 2025.

Negatives

The company reported no revenue for the three months ended March 31, 2025.
The company reported a net loss attributable to vTv Therapeutics Inc. of $5.092 million, or $0.77 per share, for the three months ended March 31, 2025.
The company has an accumulated deficit of $304.8 million as of March 31, 2025.
The company's financial statements include a going concern warning.

Risks

The company's ability to continue as a going concern is dependent on raising additional capital.
The successful development of the company's clinical and preclinical drug candidates is highly uncertain.
The company faces risks associated with tariffs and other trade restrictions, which may have a material adverse impact on its results of operations and financial condition.
Disruptions at the FDA and other government agencies could hinder their ability to approve new products in a timely manner.
The company's future capital requirements will depend on many factors, including the progress, costs, results, and timing of clinical trials, regulatory approvals, and commercialization efforts.

Future Outlook

The company expects top-line data from the CATT1 study in the second half of 2026 and plans to initiate two international registrational studies for cadisegliatin in type 1 diabetes in 2027. A Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes, in partnership with G42 Investments, is expected to begin in 2025.

Industry Context

The company is focused on developing therapies for metabolic diseases, particularly type 1 diabetes, where there is a need for adjunctive therapies to insulin. The FDA's draft guidance permitting the use of hypoglycemia as an endpoint to support a label claim is a positive development for the company's CATT1 trial.

Comparison to Industry Standards

It is difficult to compare vTv Therapeutics directly to industry standards without knowing the specific stage and type of their lead compound.
However, similar companies in the clinical-stage pharmaceutical industry include Provention Bio (now part of Sanofi), which focuses on autoimmune diseases including type 1 diabetes, and Zealand Pharma, which develops peptide-based medicines for metabolic and other diseases.
Provention Bio's teplizumab (Tzield) received FDA approval for delaying the onset of stage 3 type 1 diabetes in at-risk individuals, demonstrating the potential for disease-modifying therapies in this space.
Zealand Pharma has several compounds in clinical development for diabetes and obesity, showcasing the ongoing innovation in metabolic disease treatments.
vTv Therapeutics' cadisegliatin aims to address hypoglycemia in type 1 diabetes, a significant unmet need, and its success will depend on the CATT1 trial results and subsequent registrational studies.

Related Party Transactions

MacAndrews & Forbes Incorporated directly or indirectly controls 577,108 shares of Class B common stock and 912,982 shares of the Company's Class A common stock, representing approximately 46.7% of the combined voting power.
The Company has entered into several agreements with MacAndrews or its affiliates, including Letter Agreements, an Exchange Agreement, and a Tax Receivable Agreement.
The Investor Rights Agreement was amended on February 27, 2024, to alter M&F governance rights that now entitles M&F the right to designate two members of our Board of Directors.

Stakeholder Impact

Shareholders: The company's financial performance and the progress of its clinical trials will impact shareholder value.
Employees: The company's ability to continue as a going concern will impact job security.
Patients: The successful development of cadisegliatin could provide a new treatment option for type 1 diabetes.
Partners: The company's partnerships with G42 Investments and Newsoara Biopharma are important for the development and commercialization of its drug candidates.

Next Steps

Continue the CATT1 trial and expect top-line data in the second half of 2026.
Design two international registrational studies for cadisegliatin in type 1 diabetes, expected to start in 2027.
Initiate a Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes, in partnership with G42 Investments, expected to begin in 2025.
Evaluate financing strategies to increase the company's cash runway.

Key Dates

Date	Description
2007-02-28	Date of the Novo License Agreement concerning Glucokinase Activator Project with Novo Nordisk A/S.
2015-04	vTv Therapeutics Inc. was incorporated in the state of Delaware.
2015-08	vTv Therapeutics Inc. completed its IPO.
2017-08-01	Date of JDRF International Member.
2017-08-31	Date of JDRF International Member.
2019-05	Amendment to the Novo License Agreement to create milestone payments applicable to certain specific and non-specific areas of therapeutic use.
2019-08	The Company leased office space for its headquarters location under an operating lease.
2020	The Newsoara License Agreement was amended to change certain future milestone payments and patent rights (the First Newsoara Amendment).
2021	The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes.
2022-05-31	Date of G42 Investments Transaction.
2022-07-22	Date of CinPax and CinRx Transaction.
2022-11	The Company entered into a second amendment to the lease, (i) to reduce the square footage and (ii) to extend the lease term, which constituted a modification event under ASC 842 and, the lease classification for the asset remains as an operating lease.
2022-11-22	CinPax paid the Company $4.0 million in the form of a non-interest-bearing promissory note.
2023-02-28	The Company and G42 Investments amended the G42 Purchase Agreement and modified the G42 Promissory Note to accelerate the payment due under the note.
2023-05	The FDA issued new draft guidance on Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.
2023-11-20	The Company filed an amendment to its Amended and Restated Certificate of Incorporation as amended, to effect a reverse stock split at a ratio of 1-for-40.
2024-02-27	The Company entered into a securities purchase agreement (the Securities Purchase Agreement) with certain institutional accredited investors (the Private Placement Investors).
2024-02-28	The Company entered into the TD Cowen Sales Agreement, pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A common stock, having an aggregate offering price of up to $50.0 million (the TD Cowen ATM Offering).
2024-03-05	The Company entered into a letter agreement with the Private Placement Investors pursuant to which the Private Placement Investors agreed to exchange an aggregate of 116,493 Private Placement Shares for an aggregate of 116,590 Private Placement Pre-Funded Warrants.
2024-06-26	The Company entered into the second amendment to the Newsoara License Agreement (the Second Newsoara Amendment) which expanded the global license contingent upon Newsoara paying an upfront global rights fee (the Upfront Fees) of $20.0 million.
2024-07-26	The FDA issued a clinical hold for the cadisegliatin program, including the CATT1 trial, based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy.
2024-09-17	The Company sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million.
2025-03-14	The FDA removed the clinical hold on the cadisegliatin program.
2025-03-31	End of the quarterly period.
2025-05	The Company screened the first subject in the reinitiated CATT1 study.
2025-05-15	Date of the report.
2026	The Company expects to have top-line data from the CATT1 study in the second half of 2026.
2027	The Company expects to start two international registrational studies for cadisegliatin in type 1 diabetes.

Keywords

cadisegliatin, type 1 diabetes, glucokinase activator, CATT1 trial, clinical hold, FDA, financial results, vTv Therapeutics, metabolic diseases, pharmaceutical

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